FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This document is a 510(k) cleared device, meaning it is substantially equivalent to a predicate device. As such, it is not required to provide a study that proves the device meets the acceptance criteria but rather a study to demonstrate its equivalence.

Here's the breakdown of the information that can be extracted from the provided text regarding the AViTA Infrared Thermometer with Bluetooth Model no.: TS28B:

1. A table of acceptance criteria and the reported device performance

The provided text from the FDA 510(k) clearance letter does not include specific acceptance criteria or detailed reported device performance (e.g., accuracy, precision values). The letter states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices. For a 510(k) submission, the manufacturer would have submitted testing data demonstrating that their device performs as intended and is as safe and effective as the predicate device. However, these specific test results and acceptance criteria are not typically included in the public FDA clearance letter.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not available in the provided document. A 510(k) clearance letter does not usually contain details about the sample size or data provenance for the underlying studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not available in the provided document. Given that this is a medical device for measuring body temperature, the "ground truth" would likely be established using a highly accurate reference thermometer, not expert interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not available in the provided document. Adjudication methods are more relevant for subjective evaluations, such as image interpretation. For a thermometer, the measurement is objective.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable here. This type of study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. This device is a thermometer for direct measurement, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

The device is an infrared thermometer. Its performance is inherently "standalone" in that it directly measures temperature. It does not employ an algorithm that requires human-in-the-loop performance in the way AI-driven diagnostic tools do. The performance evaluation would focus on its accuracy and precision against a reference standard. Specific details of such a test are not provided in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a clinical electronic thermometer, the ground truth would typically be established by comparison to a highly accurate reference thermometer (e.g., a calibrated clinical mercury thermometer or a highly precise electronic thermometer that serves as a standard). This information is not explicitly stated in the provided document.

8. The sample size for the training set

This information is not applicable in the context of this device as described. Infrared thermometers are not typically "trained" using a dataset in the way a machine learning algorithm is. Their performance is based on their physical sensing capabilities and calibration.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated in point 8.

Summary

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.